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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01715597
Other study ID # SNUBH_GO_016
Secondary ID
Status Completed
Phase Phase 3
First received October 22, 2012
Last updated October 28, 2017
Start date December 2012
Est. completion date October 2017

Study information

Verified date October 2017
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators want to know whether the intravenous ascorbic acid would reduce the blood loss during laparoscopic myoma surgery. The investigators randomized patients into intravenous ascorbic acid group and placebo group and examined the blood loss in both groups.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- uterine myoma

- be planning to laparoscopic myomectomy

- images ; the number of myoma <4

- images ; the diameter of the largest myoma <9cm

Exclusion Criteria:

- be planning other surgery in addition to laparoscopy

- clinically significant coagulation abnormality

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ascorbic acid
ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour
Normal saline
normal saline 500ml IV

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Gyeongg-ido

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other time of operation during laparoscopic myomectomy
Other the amount of transfusion during laparoscopic myomectomy
Other the difference of hemoglobin postoperative day 1 hemoglobin - preoperative hemoglobin + hemoglobin increased by transfusion (hemoglobin 1 per RBC 1 pack transfusion) postoperative day 1
Other acute urinary retention 2days after the operation
Primary blood loss during laparoscopic myomectomy
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